Device recall
Z-2121-2010: MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-2121-2010 |
|---|---|
| Recall event | 56063 |
| Product | MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K040899 |
| FEI number | 2183502 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database